Medical Policy Vision Surgeries for Refractive Errors

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1 Medical Policy Vision Surgeries for Refractive Errors Effective Date: April 1, 2016 Subject: Vision Surgeries for Refractive Errors Overview: Vision surgeries are surgical procedures and/or laser treatments that alter the cornea of the eye to correct myopia, hyperopia, and astigmatism. Policy and Coverage Criteria: Harvard Pilgrim considers certain surgical procedures medically necessary to correct refractive errors caused by surgical error, injury, or the physical inability to use both eyeglasses and contact lenses. Covered procedures may include ANY of the following: Astigmatic Keratotomy Epikeratoplasty/Lamellar Keratoplasty Penetrating Keratoplasty Intrastromal Corneal Ring Segments (INTACS) Laser epithelial keratomileusis (LASEK) Harvard Pilgrim considers surgical procedures (including those listed above) to correct routine or natural refractive errors not considered medically necessary. Non-covered procedures include, but are not limited to, the following: Radial Keratotomy Hexagonal Keratotomy Keratophakia Standard Keratomileusis (ALK) Implantable contact lens Photorefractive keratectomy (PRK) Laser in-situ keratomileusis (LASIK) Exclusions: N/A Supporting Information: 1. Technology Assessment Astigmatic keratotomy: Astigmatic keratotomy is a surgical procedure that reshapes the cornea from an oval shape into a spherical shape to correct astigmatism. Radial keratotomy: Radial keratotomy is a surgical procedure that is used to correct myopia. Radial incisions are made in the cornea of the eye causing the sides of the cornea to bulge outward and flatten the center of the cornea. Hexagonal keratotomy: Hexagonal keratotomy is a surgical procedure that is used to correct hyperopia. Circumferential connecting hexagonal incisions are made to induce central cornea steepening. Epikeratoplasty: Epikeratoplasty is the removal of the corneal epithelium which is then replaced with a donor s corneal disc. Penetrating keratoplasty: Penetrating keratoplasty is the removal of the full cornea which is then replaced by a donor s full cornea. Keratophakia: Keratophakia is the placement of a plastic or donor lens in the cornea to correct a refractory error. Intrastromal Corneal Ring Segments (INTACS): INTACS are inserts that are surgically implanted into the cornea resulting in the reshaping and remodeling of the cornea.

2 Automated Lamellar Keratoplasty (ALK): ALK is a procedure where a thin flap of the cornea is cut and tissue from the cornea stroma, under the flap, is removed and the flap is replaced. Implantable contact lens: The Verisyse Phakic Intraocular Lens (IOL) is made of plastic, and is attached in front of the iris. It's designed for people aged 21 years or older who have stable vision with a change in refraction of less than 0.5 diopters in six months. The Visian Implantable Collamer Lens (ICL) is made of collamer, a substance that occurs naturally in the body, and is implanted behind the iris in front of the natural lens of the eye. Laser in situ keratomileusis: LASIK is a refractive surgery procedure that reshapes the surface of the cornea with an excimer laser to focus visual images directly onto the retina and improve visual acuity. The LASIK technique is designed to correct certain refractive errors and eliminate or reduce the need for corrective lenses. Photorefractive keratectomy: PRK is an effective treatment of low to moderate myopia, myopia with astigmatism, and low to moderate hyperopia without astigmatism. The corneal epithelium in the ablation zone is removed or pushed to the side and the laser treatment in then applied to the exposed corneal stroma. Laser epithelial keratomileusis: LASEK is similar to LASIK, however, with LASEK the corneal flap is very thin which avoids the complication of corneal ectasia. Additionally, the equipment used in LASEK is not as complicated as LASIK and has lower risk of surgical flap complications. LASEK may cause greater pain than LASIK and have a slower optical recovery time. Phototherapeutic keratectomy: PTK is a similar procedure to PRK, however, PTK is used for the correction of particular corneal diseases, whereas PRK uses an excimer laser for the correction of refractive errors in persons with otherwise non-diseased corneas. 2. Literature Review Hayes, Inc (2014) states that there is a moderately large body of evidence of low quality suggesting that implantation of INTACS is reasonably safe and provides some improvements in visual outcomes for patients who have keratoconus. Studies also suggest that the efficacy of INTACS is essentially the same as the efficacy of similar ocular implants. Vega-Estrada et al (2015) analyzed whether implantation of intrastromal corneal ring segments (ICRS) influences the progression of keratoconus in young patients. The study evaluated 18 eyes in 15 patients. Six months postoperatively, there was improvement in the uncorrected and corrected distance visual acuities and all refractive measurements and the mean keratometry was reduced by 4.48 D. The authors concluded that implantation of ICRS significantly improved the visual, refractive, and topographic parameters in the short term, however, regression at 5 years suggests that implantation of ICRS does not influence progressive keratoconus. Al-Muammar (2015) evaluated and compared the visual and refractive outcomes, topographic keratometry and complications of Intacs and Intacs SK for mild to moderate keratoconus. At 6 months postoperatively there were significant improvements in UDVA, CDVA, manifest sphere, SE, minimum K, maximum K, and average K. There were no complications in both groups. Both models of Intacs significantly improved vision and refractive outcomes, and topographic keratometry in cases of mild to moderate keratoconus. Ozerturk et al (2012) compared the visual and refractive results in eyes with advanced keratoconus having deep anterior lamellar keratoplasty (DALK) with those having intrastromal corneal ring segment (ICRS) implantation. There were 36 eyes in the DALK group and 30 eyes in the ICRS group. Both groups had a significant increase in UDVA and CDVA from preoperatively to 24 months postoperatively. The DALK group had a significantly greater improvement than the ICRS group in UDVA and CDVA 24 months postoperatively. Both groups had significant improvement in spherical equivalent refractive error, manifest sphere, and manifest cylinder. The DALK group had a significantly greater mean reduction in SE and manifest cylinder than the ICRS group. Both groups had a significant postoperative reduction in the maximum and minimum K-values, however, the mean reduction was significantly greater in the DALK group. Bedi et al (2012) evaluated the long-term rate of progression of keratoconus in 92 eyes implanted with Intacs at 5 year follow-up. 91.3% of eyes demonstrated no progression between 1- and 5-year follow-up.

3 No differences were noted in mean steep, flat, and average keratometry; manifest refraction spherical equivalent; and uncorrected and corrected distance visual acuity between 1-and 5- year follow-up. Kubaloglu et al (2011) compared astigmatic keratotomy outcomes in high astigmatism after deep anterior lamellar keratoplasty (DALK) and after penetrating keratoplasty (PK) in keratoconus patients. Visual acuity improved at 6 month follow up in both groups. The authors concluded that astigmatic keratotomy for the treatment of postkeratoplasty astigmatism after DALK and PK in keratoconus patients is safe and effective. Kymionis et al (2007) evaluated long-term follow-up of Intacs microthin prescription inserts for the management of keratoconus in 17 eyes. At five year follow-up, the spherical equivalent error was significantly reduced. After five years, intracorneal ring segments implantation improved UCVA, BSCVA, and refraction in the majority of the keratoconus patients. Colin et al (2007) evaluated the long-term safety and efficacy of Intacs segments for the treatment of keratoconus in terms of intraoperative and postoperative complications, visual outcome, restoration of contact lens tolerance, and inhibition of disease progression. At 2 years, UCVA and BCVA significantly improved in 80.5% and 68.3% of eyes. The proportion of eyes with a BCVA >or=0.5 increased from 22.0% at baseline to 51.2% and 53.7% at 1 year and 2 years. The mean keratometry readings decreased from /- 5.6 D preoperatively to /- 5.3 D at 1 year and /- 4.9 D at 2 years. Contact lens tolerance was restored in over 80% of cases. The authors concluded that Intacs implantation is a safe and efficacious treatment for keratoconus. Significant and sustained improvements in objective visual outcomes were achieved in most cases, with restoration of contact lens tolerance. Alio et al (2006) conducted a retrospective study comprising of 13 eyes to evaluate the long-term results and stability of Intacs implantation for keratoconus correction. There was a significant increase in mean BSCVA and significant decrease in mean inferior-superior asymmetry. The authors concluded that Intacs increased the BSCVA and decreased inferior-superior asymmetry with stability up to 36 months. Goosey et al (1991) compared penetrating keratoplasty to epikeratoplasty in the surgical management of keratoconus. Of 47 eyes with keratoconus, 31 were treated with epikeratoplasty and 16 with penetrating keratoplasty. The penetrating keratoplasty procedure resulted in a higher percentage of eyes that had visual acuity of 20/20 than the epikeratoplasty group. 31% of the eyes in the penetrating keratoplasty group had graft failures while no serious complications were noted in the epikeratoplasty group. Laser Surgeries: Hayes, Inc. (2007) reports there is a moderate level of evidence to support the safety and efficacy of LASIK. LASIK is most appropriate in patients with low or moderate myopia or myopic astigmatism who choose to undergo surgical refraction correction. There is less evidence for the use of LASIK in hyperopia, and very little evidence about overall patient satisfaction regarding visual acuity, side effects, or need for corrective lenses after surgery. More research is needed to evaluate the long-term clinical efficacy, predictability, safety, and stability of LASIK for various levels of myopia and hyperopia. Chao et al (2015) evaluated changes in nerve morphology, tear neuropeptide, and dry eye to establish the relationship between reinnervation and dry eye and to assess the role of tear neuropeptides in reinnervation in 20 patients post-lasik. Corneal nerve morphology, tear neuropeptide concentration, and dry eye were monitored prior to LASIK and 1 day, 1 week, 1, 3, and 6 months post-lasik. There was no change in dry eye symptoms and tear function, except for osmolarity, post-lasik. There was an immediate decrease in corneal nerve morphology that remained by 6 months post-lasik. The concentration of the tear neuropeptide SP increased at 3 months post-lasik. The authors found an inverse relationship between reinnervation and dry eye symptoms post-lasik, confirming that post-lasik dry eye is a neuropathic disease. Bamashmus et al (2015) evaluated subjective quality of vision and patient satisfaction after LASIK for myopia and myopic astigmatism in 200 patients. Seven scales were formulated to cover specific aspects of the quality of vision including; global satisfaction; quality of uncorrected and corrected vision; quality of night vision; glare; daytime driving and; night driving. The preoperative myopic sphere was ± 1.70 D and myopic astigmatism was 0.90 ± 0.82 D. There were 96% of eyes within ± 1.00 D of the targeted correction. The uncorrected visual acuity was 20/40 or better in 99% of eyes postoperatively. A total of 98.5% of patients was satisfied or very satisfied with their surgery, 98.5% considered their main goal for surgery was achieved. Night driving was rated more difficult preoperatively by 6.2%, whereas 79% had less difficulty driving at night. The authors concluded that patient satisfaction with uncorrected

4 vision after LASIK for myopia and myopic astigmatism appears to be excellent and is related to the residual refractive error postoperatively. Kato et al (2008) investigated the safety and efficacy of LASIK over a 5-year postoperative period in 779 eyes with myopia or myopic astigmatism. Preoperative uncorrected visual acuity showed significant improvements at day 1 and 1 month after surgery. Improvements continued at a significant level thereafter. Postoperative manifest refraction improved with minimal but significant regression after 1 year. There was a significant decrease in corneal endothelial cell counts at 5 years after surgery. The authors concluded that LASIK is an effective and safe procedure for correcting myopia and myopic astigmatism as long as inclusion and exclusion criteria are strictly followed. Alio et al (2008) evaluated the long-term outcomes of LASIK for high myopia in 196 myopic eyes. All patients were evaluated at 3 months, 1, 2, 5, and 10 years postoperatively with the outcome measures being refractive predictability and stability, mean corneal keratometry, topographical cylinder, safety, efficacy, stability of visual acuity, and postoperative complications. At 10 year, 42% of eyes were within +/-1.00 D and 61% were within +/ D. 27.5% of eyes underwent retreatment due to under correction and/or regression. 40% showed a postoperatively uncorrected visual acuity of 20/40 or better. The authors concluded that LASIK for myopia over -10 D is a safe procedure with myopic regression that slows down with time and a high rate of best spectacle-corrected visual acuity increase in the long-term. Zadok et al (2000) evaluated the efficacy, safety, and predictability of hyperopic LASIK in 72 eyes in patients with up to diopters hyperopia. Groups were split into a low hyperopia group (<3.00D) and moderate hyperopia group (>/=3.00D). At 6 months, in the low hyperopia group had a mean MSE of / D, with 88.9% eyes within 1 D of emmetropia compared with / D and 51.8% within 1 D of emmetropia in the moderate hyperopia group. Uncorrected visual acuity was 20/40 or better in 95.6% and in 77.8% eyes in the low and moderate hyperopia groups. 25% required retreatment to correct residual hyperopia, 20.0% in the low hyperopia group and 33.3% in the moderate hyperopia group. Retreatments resulted in an MSE of / D and / D in the low and moderate hyperopia groups. Lindstrom et al (2000) assessed the safety and efficacy of LASIK for secondary hyperopia and hyperopic astigmatism in a prospective, nonrandomized, self-controlled interventional study including 30 patients. Spherical equivalent (SE) was /- 0.79D before surgery, /- 1.00D at 6 months post surgery, and /- 1.08D at 1 year post surgery. At 6 months, 84% of patients with secondary hyperopia had uncorrected visual acuity of 20/40 or better, 76% were within +/-1D of emmetropia. At 1 yea, 85% had uncorrected visual acuity of 20/40 or better and 85% were within +/-1D of emmetropia. The authors concluded that he data suggests that LASIK for consecutive hyperopia from +0.5 to D and astigmatism from 0 to D using the VISX STAR S2 is safe and effective. El-Maghraby et al (1999) compared the effectiveness, safety, and stability of excimer LASIK and PRK for low-to-moderate myopia in a prospective, randomized, bilateral study involving 33 patients with a manifest refraction of to diopters. For each patient, one eye received LASIK and the other received PRK. At day one post surgery, 81% of patients reported no pain in the LASIK treated eye, whereas 0% reported being pain free in the PRK treated eye. At 3 to 4 days post surgery, 80% of LASIK treated eyes and 45% of PRK treated eyes improved or remained within 1 line of baseline spectaclecorrected visual. At 2 year follow up, 61% of LASIK and 36% of PRK treated eyes achieved an uncorrected visual acuity of 20/20 or better, with no difference in refractive outcome between techniques. Patients initially showed a preference for LASIK by a 2 to 1 margin at 1 year follow up, but no preference was shown at 2 year follow up. Dulaney et al (1998) evaluated the visual and refractive results of LASIK for mild to moderate myopia with or without astigmatism in 124 eyes. Eyes with a preoperative spherical equivalent from to diopters were included in the study. All eyes were completely re-epithelialized by the first postoperative day. Uncorrected visual acuity was 20/40 or better in 81% of eyes at day 1 and 91% at 6 months. 72% of eyes were included in 6 month follow up. The authors concluded that LASIK provided rapid visual recovery with satisfactory visual and refractive outcomes in eyes with myopia with or without astigmatism. Zhao et al (2010) examined the differences between LASEK and PRK for myopia in a systematic review and meta-analysis. They identified 12 studies comparing PRK with LASEK for myopia. No differences in outcomes were observed between the two procedures and LASEK showed no benefit over PRK.

5 Teus et al (2008) compared the visual results after LASEK and epi-lasik to correct myopia in 94 eyes. The groups were matched for age and refraction. The authors concluded that their results suggested a faster visual rehabilitation and better safety and efficacy outcomes after LASEK compared to epi-lasik. Pop et al (2000) compared PRK with LASIK in 107 eyes at 1, 3, 6, and 12 months postoperatively. 70% of eyes were evaluated at 12-month follow-up. At 12 month follow-up, 83% of LASIK and 86% of PRK cases had uncorrected visual acuities of 20/20 or better. Refractions within +/- 0.5 D represented 78% of the LASIK eyes and 83% of the PRK eyes. LASIK patients reported halos twice as often as PRK patients. The authors concluded that PRK and LASIK achieved equal refractive outcomes at all postoperative follow-ups. Hersh et al (1998) conducted a randomized clinical trial of PRK and LASIK in 220 eyes to analyze visual acuity, predictability, and stability of refraction, corneal haze, and flap complications. One day after surgery, 0.0% and 4.5% eyes in the PRK group saw 20/20 and 20/40 or better uncorrected while 10% and 68.6% eyes in the LASIK group saw 20/20 and 20/40 or better. At 6 months after PRK, 19.1% and 66.2% eyes saw 20/20 and 20/40 or better while after LASIK, 26.2% and 55.7% eyes saw 20/20 and 20/40 or better, respectively. After PRK, 57.4% were within 1.0 D of attempted correction compared with 40.7% in the LASIK group; however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, 11.8% had a decrease in spectaclecorrected visual acuity of two Snellen lines or more; after LASIK, 3.2% had a decrease of two lines or more. Only two eyes had postoperative spectacle-corrected visual acuity less than 20/32. The authors concluded that although improvement in uncorrected visual acuity is more rapid in LASIK than in PRK, efficacy outcomes in the longer term generally are similar between the two procedures. 3. Benchmarks Aetna: Aetna considers correction of surgically induced astigmatism with a corneal relaxing incision (including limbal relaxing incisions) or corneal wedge resection medically necessary if the member had previous penetrating keratoplasty (corneal transplant) within the past 60 months or cataract surgery within the last 36 months and both of the following criteria are met: The degree of astigmatism must be 3.00 diopters or greater; and The member must be intolerant of glasses or contact lenses. Aetna's standard HMO benefit plan excludes coverage of "radial keratotomy, including related procedures designed to surgically correct refractive errors". Traditional benefit plans generally exclude coverage for services "for or related to any eye surgery mainly to correct refractive errors". These exclusions apply to radial keratotomy (RK), astigmatic keratotomy, PRK, photoastigmatic keratectomy (PARK), laser-in-situ keratomileusis (LASIK), keratomileusis, epikeratophakia, implantation of intrastromal corneal ring segments, and other refractive surgical procedures. For plans that do not have a specific contractual exclusion of refractive surgery, refractive surgery is considered experimental and investigational or not medically necessary, as is outlined below. For the U.S. Food and Drug Administration (FDA)-approved indications and indications accepted by the American Academy of Ophthalmology (AAO), refractive surgical procedures are considered not medically necessary, because spectacles or contact lenses have been shown to provide more accurate corrections of refractive errors than refractive surgery. 1. Radial keratotomy (RK) is not considered medically necessary for the treatment of myopia ranging from to diopters because this refractive error can be corrected satisfactorily with eyeglasses or contact lenses. Radial keratotomy is considered investigational for treatment of myopia greater than diopters and all other refractive errors because its effectiveness for these indications has not been established. 2. Minimally invasive radial keratotomy (Mini-RK) is considered experimental and investigational for the treatment of myopia and other indications.

6 3. Astigmatic keratotomy (AK) (arcuate incision, corneal wedge resection) is considered medically necessary when performed for the correction of surgically induced astigmatism following medically indicated cataract removal or corneal transplant surgery. Astigmatic keratotomy is considered investigational for treatment of all other refractive errors because its effectiveness for these indications has not been established. 4. Hexagonal Keratotomy (HK) is considered experimental and investigational the treatment of hyperopia, or presbyopia following radial keratotomy because its effectiveness for these indications has not been established. 5. Standard keratomileusis (ALK) is considered investigational for treatment of all refractive errors because its effectiveness for trestment of refractive errors has not been proven. 6. Epikeratoplasty (or epikeratophakia) is considered medically necessary for the following indications: (i) for the treatment of childhood aphakia since contact lenses are difficult for children to use and intraocular lens implants may result in long-term complications in children; (ii) for the treatment of scarred corneas and corneas affected with endothelial dystrophy; (iii) for the treatment of adult aphakia in circumstances where secondary implantation of an intra-ocular lens is not feasible because reentering the eye could affect outcome (e.g., vitreous in the anterior chamber, history of uveitis, disorganized anterior chamber that cannot support an intraocular lens, significant corneal endothelial disease, or gross corneal irregularity after trauma). This procedure is considered investigational for correction of refractive errors and for all other cases of adult aphakia. 7. Keratophakia is considered investigational for correction of refractive errors because its effectiveness for the treatment of refractive errors has not been proven. 8. Lamellar keratoplasty (non-penetrating keratoplasty) is considered medically necessary for treatment of corneal diseases, including scarring, edema, thinning, distortion, dystrophies, degenerations, and keratoconus. It is considered investigational for pterygium and when performed solely to correct astigmatism and other refractive errors because its effectiveness for these indications has not been established. 9. Penetrating keratoplasty (PK) (corneal transplantation, perforating keratoplasty) is considered medically necessary for treatment of corneal diseases, including: (i) to improve poor visual acuity caused by an opaque cornea; (ii) to remove active corneal disease, such as persistent severe bacterial, fungal, or amebic inflammation of the cornea (keratitis) after appropriate antibiotic therapy; (iii) to restore altered corneal structure or to prevent loss of the globe that has been punctured: (iv) to treat corneal diseases, including bullous keratopathy, keratoconus, corneal scar with opacity, keratitis, corneal transplant rejection, Fuch's dystrophy, corneal degeneration, other corneal dystrophies, corneal edema, and herpes simplex keratitis. Penetrating keratoplasty is considered investigational when performed solely to correct astigmatism or other refractive errors because its effectiveness for these indications has not been established. Tissue procurement, preservation, storage and transportation associated with medically necessary corneal transplantation are also considered medically necessary. 10. Intrastromal corneal ring segments (INTACS) (Addition Technology, Sunnyvale, CA) are considered not medically necessary for adults with mild myopia (from -1.0 to -3.0 diopters) that have less than 1 diopter of astigmatism. Aetna considers intrastromal corneal ring segments experimental and investigational for children, for persons with moderate-to- severe myopia (greater than -3.0 diopters), for persons with more than 1 diopter of astigmatism, and for hyperopia because their effectiveness for these indications has not been established. Intrastromal corneal ring segments are considered medically necessary for reduction or elimination of myopia or astigmatism in persons with keratoconus or pellucid marginal degeneration who are no longer able to achieve adequate vision using contact lenses or spectacles and for whom corneal transplant is the only remaining option. Intrastromal corneal ring segments are considered experimental and investigational for other indications because their effectiveness for indications other than the ones listed above has not been established. Note: Where indicated for keratoconus or pellucid marginal degeneration, INTACS are not excluded from coverage under plans that exclude coverage of refractive surgery. Please check benefit plan descriptions. 11. Conductive Keratoplasty is considered not medically necessary for the treatment of individuals who are at least 40 years of age, who have mild-to- moderate hyperopia (0.75 D to 3.25 D), who have 0.75 D or less astigmatism, and whose eyesight has changed very little over the previous 12 months (as demonstrated by a change of less than 0.50 D in refraction). Conductive keratoplasty is

7 considered experimental and investigational for keratoconus and all other indications because its effectiveness for these indications has not been established. 12. Methods of thermokeratoplasty other than conductive keratoplasty (see above), such as the superficial treatment of Gassett and Kaufman for keratoconus, holmium:yag laser thermokeratoplasty (laser thermokeratoplasty or LTK), or the hot needle of Fyodorov, are considered experimental and investigational for treatment of refractive errors, keratoconus, and all other indications because their effectiveness for these indications has not been established. 13. Orthokeratology is considered investigational for correction of refractive errors and all other indications because its effectiveness for these indications has not been established. 14. Scleral Expansion Surgery is considered experimental and investigational for presbyopia and all other indications because its effectiveness for these indications has not been established. 15. Intraocular lens implants (clear lens extraction) (aphakic intra-ocular lenses (IOLs)) are considered not medically necessary for correction of presbyopia, hyperopia, and myopia because these refractive errors can be corrected satisfactorily with eyeglasses or contact lenses. Intra-ocular lens implants are considered medically necessary for persons with aphakia 16. Implantable contact lenses (without lens extraction) (phakic IOLs) (e.g., the Artisan [model 204 and 206] phakic IOL, also known as the Verisye [e.g., VRSM5US and VRSM6US] phakic IOL, and the Collamer lens [e.g., Visian ICL]) is considered not medically necessary for severe myopia because these refractive errors can be corrected satisfactorily with eyeglasses or contact lenses. The Artisan (model 204 and 206) phakic IOL is considered not medically necessary for: (i) the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth (acd) greater than or equal to 3.2 millimeters; and, (ii) individuals with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters. The Visian ICL is considered not medically necessary for adults 21 to 45 years of age to (i) correct myopia ranging from -3.0 diopters to less than or equal to diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; (ii) to reduce myopia ranging from greater than diopters to diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; and (iii) with an anterior chamber depth (acd) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation. Phakic IOLs are considered experimental and investigational for all other indications because their effectiveness for indications other than the ones listed above has not been established. 17. Photorefractive keratectomy (PRK) and Photoastigmatic keratectomy (PARK or PRK-A) are considered not medically necessary for individuals with hyperopia of up to 6.0 diopters and myopia of up to diopters, with or without astigmatism up to 4.0 diopters, because the refractive corrections achieved with PRK and PARK are less precise than that achieved by eyeglasses or contact lenses. Photorefractive keratectomy and PARK are considered investigational for individuals with hyperopia greater than 6.0 diopters, myopia greater than diopters, astigmatism greater than 4.0 diopters, and for all other refractive errors. This policy is based on the FDA approved indications for PRK and PARK. 18. Laser-in-situ keratomileusis (LASIK) is considered not medically necessary for treatment of myopia between -1.0 and diopters, with or without astigmatism up to 5.0 diopters, because this can be corrected satisfactorily with eyeglasses or contact lenses. Laser-in-situ keratomileusis is also considered not medically necessary for treatment of hyperopia up to diopters with or without astigmatism up to 5 diopters. Laser-in-situ keratomileusis is considered investigational for treatment of myopia greater than diopters or hyperopia greater than diopters, for treatment of persons with astigmatism greater than 5.0 diopters, and for all other refractive errors. This clinical policy is based on the FDAapproved indications for LASIK. Aetna considers phototherapeutic keratectomy (PTK) medically necessary for members with any of the following corneal conditions: Corneal scars and opacities (including post-traumatic, post-infectious, post-surgical, and secondary to pathology); or Epithelial membrane dystrophy; or Irregular corneal surfaces due to Salzmann s nodular degeneration or keratoconus nodules; or

8 Recurrent corneal erosions when more conservative measures (e.g., lubricants, hypertonic saline, patching, bandage contact lenses, gentle debridement of severely aberrant epithelium) have failed to halt the erosions; or Superficial corneal dystrophy (including granular, lattice, and Reis-Buckler s dystrophy). Aetna considers PTK experimental and investigational for the treatment of infectious keratitis and all other indications because it has not been shown to be safe and effective for these indications. Anthem: Correction of surgically induced astigmatism with a corneal relaxing incision or corneal wedge resection is considered medically necessary when all of the following criteria are met: 1. The astigmatism is the result of a previous cataract surgery, medically necessary refractive surgery, sclera buckling for retinal detachment, or corneal transplant; AND 2. The degree of astigmatism is 3.00 diopters or greater; AND 3. The medical record documents inadequate functional vision with any of the following: (a) contact lenses, (b) spectacles, or (c) contact lenses and spectacles. Epikeratoplasty (epikeratophakia) is considered medically necessary for either of the following conditions: 1. Correction of refractive errors of acquired or congenital aphakia; OR 2. Hypermetropia following cataract surgery in individuals unable to receive intraocular lens. Implantation of intrastromal corneal ring segments (INTACS Prescription Inserts, Addition Technology, Sunnyvale, CA) is considered medically necessary in individuals with keratoconus who meet all of the following criteria: 1. Progressive deterioration in vision, such that individuals can no longer achieve adequate functional vision on a daily basis with either contact lenses or spectacles; AND years of age or older; AND 3. Presence of clear central cornea; AND 4. Corneal thickness of 450 microns or greater at the proposed incision site; AND 5. Who have corneal transplantation as the only remaining option to improve their functional vision. Procedures considered not medically necessary include, but are not limited to, the following: 1. Correction of surgically induced astigmatism with a corneal relaxing incision or corneal wedge resection, except for the small subset of individuals noted above; 2. Laser in-situ keratomileusis (LASIK), except for the small subset of individuals noted above; 3. Laser epithelial keratomileusis (LASEK), except for the small subset of individuals noted above; 4. Epikeratoplasty (epikeratophakia), except for the small subset of individuals as noted above; 5. Laser thermal keratoplasty (LTK); 6. Photorefractive keratectomy (PRK) and photoastigmatic keratectomy (PARK or PRK-A), except for the small subset of individuals noted above; 7. Radial keratotomy and its variants; 8. Implantable contact lenses without lens extraction (phakic intraocular lenses) including, but not limited to, Artisan Phakic Intraocular Lens also known as Verisyse Phakic Intraocular Lens (Ophtec USA, Inc., Boca Raton, FL) and Visian ICL Implantable Collamer Lens (Starr Surgical Company, Monravia, CA); 9. Clear lens extraction (CLE) with or without implantation of an accommodating or nonaccommodating lens; 10. Implantation of intrastromal corneal ring segments (INTACS) for the correction of myopia; 11. Conductive keratoplasty to treat presbyopia (that is, ViewPoint CK System [Refracrtec Inc., Irvine, CA]); 12. Keratophakia; 13. Orthokeratology; 14. Standard keratomileusis. Laser in-situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), photorefractive keratectomy (PRK), and photoastigmatic keratectomy (PARK or PRK-A) are considered medically necessary when all of the following are met: 1. Prior cataract, corneal, or scleral buckling surgery for retinal detachment has been performed on this eye; AND

9 2. The medical record documents symptoms due to aniseikonia (different sizes of ocular images) or anisometropia (difference in power of refraction); AND 3. The medical record documents inadequate functional vision with any of the following: (a) contact lenses, (b) spectacles, or (c) contact lenses and spectacles; AND 4. The post-operative spherical equivalent refractive error has changed by 3 diopters when compared to the preoperative refractive error or the degree of astigmatism is 3 diopters or greater. Procedures considered not medically necessary include, but are not limited to, the following: 15. Correction of surgically induced astigmatism with a corneal relaxing incision or corneal wedge resection, except for the small subset of individuals noted above; 16. Laser in-situ keratomileusis (LASIK), except for the small subset of individuals noted above; 17. Laser epithelial keratomileusis (LASEK), except for the small subset of individuals noted above; 18. Epikeratoplasty (epikeratophakia), except for the small subset of individuals as noted above; 19. Laser thermal keratoplasty (LTK); 20. Photorefractive keratectomy (PRK) and photoastigmatic keratectomy (PARK or PRK-A), except for the small subset of individuals noted above; 21. Radial keratotomy and its variants; 22. Implantable contact lenses without lens extraction (phakic intraocular lenses) including, but not limited to, Artisan Phakic Intraocular Lens also known as Verisyse Phakic Intraocular Lens (Ophtec USA, Inc., Boca Raton, FL) and Visian ICL Implantable Collamer Lens (Starr Surgical Company, Monravia, CA); 23. Clear lens extraction (CLE) with or without implantation of an accommodating or nonaccommodating lens; 24. Implantation of intrastromal corneal ring segments (INTACS) for the correction of myopia; 25. Conductive keratoplasty to treat presbyopia (that is, ViewPoint CK System [Refracrtec Inc., Irvine, CA]); 26. Keratophakia; 27. Orthokeratology; 28. Standard keratomileusis. BCBSMA: Radial keratotomy is NOT MEDICALLY NECESSARY for the treatment of any medical condition. Epikeratophakia may be MEDICALLY NECESSARY in the treatment of aphakia. The following procedures are INVESTIGATIONAL: Keratomileusis Keratophakia The following procedures to correct disorders of refraction or accommodation, even with vision care rider are considered NOT MEDICALLY NECESSARY: Automated lamellar keratoplasty LASIK for vision correction Mini-radial keratotomy Tectonic or optic keratoplasty Photorefractive keratectomy Conductive keratoplasty, AND Hexagonal keratoplasty Lamellar keratoplasty and tectonic or optic keratoplasty may be MEDICALLY NECESSARY for medical conditions such as corneal ulcers or trauma resulting in the form of scar tissue. All other refractive keratoplasty procedures listed under the Description section of the policy are INVESTIGATIONAL. The following procedures to correct disorders of refraction or accommodation, even with vision care rider are considered NOT MEDICALLY NECESSARY: LASIK for vision correction Photorefractive keratectomy

10 Phototherapeutic keratectomy may be MEDICALLY NECESSARY when used as an alternative to a lamellar keratoplasty in the treatment of visual impairment or irritative symptoms related to corneal scars, opacities, or dystrophies extending beyond the epithelial layer. Phototherapeutic keratectomy is NOT MEDICALLY NECESSARY when used as an alternative to a superficial mechanical keratectomy in treating patients with superficial corneal dystrophy, epithelial membrane dystrophy, and irregular corneal surfaces due to Salzmann s nodular degeneration or keratoconus nodules. INVESTIGATIONAL applications of phototherapeutic keratectomy include, but are not limited to, treatment of recurrent corneal erosions and infectious keratitis. n.pdf Tufts: Tufts Health Plan may authorize the coverage of phototherapeutic keratectomy when the Member requires the procedure for the treatment of one of the following documented conditions: Corneal scars Degeneration and dystrophy involving the superficial layer of the cornea Anterior basement dystrophy and recurrent epithelial erosion that is recalcitrant to standard therapeutic regimens Tufts Health Plan may authorize the coverage of Laser-in-situ keratomileusis for Members who have one of the following conditions and are contact lens intolerant: Anisometropia resulting in a 2 diopter difference following conventional cataract surgery, anterior segment glaucoma surgery or corneal transplant. Astigmatism resulting in a 2 diopter difference following conventional cataract surgery, anterior segment glaucoma surgery or corneal transplant. Tufts Health Plan will not cover laser vision correction surgery for cosmetic purposes, i.e. to replace the need to wear glasses or contact lenses. Tufts Health Plan will not cover photorefractive keratectomy. Photorefractive keratectomy (PRK) is an excimer laser procedure to correct mild to moderate myopia in otherwise healthy eyes, to replace contact lenses or eye glasses. CMS: The correction of common refractive errors by eyeglasses, contact lenses or other prosthetic devices is specifically excluded from coverage. The use of radial keratotomy and/or keratoplasty for the purpose of refractive error compensation is considered a substitute or alternative to eye glasses or contact lenses, which are specifically excluded by 1862(a)(7) of the Act (except in certain cases in connection with cataract surgery). In addition, many in the medical community consider such procedures cosmetic surgery, which is excluded by section 1862(a)(10) of the Act. Therefore, radial keratotomy and keratoplasty to treat refractive defects are not covered. Keratoplasty that treats specific lesions of the cornea, such as phototherapeutic keratectomy that removes scar tissue from the visual field, deals with an abnormality of the eye and is not cosmetic surgery. Such cases may be covered under 1862(a)(1)(A) of the Act. The use of lasers to treat ophthalmic disease constitutes opthalmalogic surgery. Coverage is restricted to practitioners who have completed an approved training program in ophthalmologic surgery Professional/Governmental Agencies

11 The American Academy of Ophthalmology (AAO) stated in their 2013 Preferred Practice Pattern on Refractive Surgery that eyeglasses are the simplest and safest means of correcting a refractive error; therefore, eyeglasses should be considered before contact lenses or refractive surgery. FDA: INTACS Indications for Use INTACCS prescription inserts are intended for the reduction or elimination of myopia and astigmatism in patients with keratonus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a corneal transplant prodeure may potentially be deferred. The specific subset of keratoconic patients proposed to be treated with INTACS prescription inserts are those patients: Who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of 450 microns or greater at the proposed incision site; and Who have corneal transplantation as the only remaining option to improve their functional vision. Codes: CPT codes considered medically necessary: Excision of lesion, cornea (keratectomy, lamellar, partial), except pterygium Corneal relaxing incision for correction of surgically induced astigmatism Corneal wedge resection for correction of surgically induced astigmatism Keratoplasty (corneal transplant); anterior lamellar Keratoplasty (corneal transplant); penetrating (except in aphakia or pseudophakia) Keratoplasty (corneal transplant); penetrating (in pseudophakia) Keratoplasty (corneal transplant); penetrating (in pseudophakia) Keratoplasty (corneal transplant); endothelial Backbench preparation of corneal endothelial allograft prior to transplantation (List separately in addition to code for primary procedure) Epikeratoplasty Keratoprosthesis Implantation of intrastromal corneal ring segments Unlisted procedure, anterior segment of eye [when specified as laser epithelial keratomileusis (LASEK) or photoastigmatic keratectomy (PRK-A)] CPT codes considered not medically necessary: Keratomileusis Keratophakia Radial keratotomy Unlisted procedure, anterior segment of eye [when used for procedures to correct naturally occurring refraction] S0800 Laser in situ keratomileusis (LASIK) S0810 Photorefractive keratectomy (PRK) References: 1. McAlinden, C. Corneal refractive surgery: past to present. Clinical and Experimental Optometry, 2012; 95: Hayes, Inc. Medical Technology Directory. Intacs for the treatment of keratoconus. Hayes, Inc. Lansdale, PA. November 25, 2014.

12 3. American Academy of Ophthalmology (AAO). Preferred Practice Patterns: Refractive Errors and Refractive Surgery. September, 2007; reprinted 2009; updated July Centers for Medicare and Medicaid Services. National Coverage Determination for Refractive Keratoplasty. NCD #80.7. Effective May 1, Available at: Accessed on September 4, U.S. Food and Drug Administration (FDA). New Humanitarian Device Approval. INTACS Prescription Inserts for Keratoconus No. H Updated July 26, Available at: Accessed on September 4, Kubaloglu, A., Coskun, E., Sari, ES., Gunes, AS., Cinar, Y., Pinero, DP., Kutluturk, I., Ozerturk, Y. Comparison of astigmatic keratotomy results in deep anterior lamellar keratoplasty and penetrating keratoplasty in keratoconus. Am J Ophthal. 2011; 151(4): Goosey, JD., Prager, TC., Goosey, CB., Bird, EF., Sanderson, JC. A comparison of penetrating keratoplasty to epikeratoplasty in the surgical management of keratoconus. Am J Ophthal. 1991; 111(2): Al-Muammar, A. Comparison of visual, refractive and topographic keratometry outcomes if Intacs and Intacs SK in mild to moderate keratoconus eyes. Middle East Afr J Ophthalmol. 2015; 22(1): Vega-Estrada, A., Alio, JL., Plaza-Puche, AB. Keratoconus progression after intrastromal corneal ring segment implantation in young patients: Five-year follow-up. J Cataract Refractive Surg. 2015; 41(6): Bedi, R., Touboul, D., Pinsard, L., Colin, J. Refractive and topographic stability of Intacs in eyes with progressive keratoconus: Five-year follow-up. J Refractive Surg. 2012; 28(6): Alio, JL., Shabayek, MH., Artola, A. Intracorneal ring segments for keratoconus correction: long-term followup. J Cataract Refract Surg. 2006; 32(6): Colin, J., Malet, FJ. Intacs for the correction of keratoconus: two-year follow-up. J Cataract Refract Surg. 2007; 33(1): Kymionis, GD., Siganos, CS., Tsiklis, NS., Anastasakis, A., Yoo, SH., Pallikaris, AI., Astyrakakis, N., Pallikaris, IG. Long-term follow-up of Intacs in keratoconus. Am J Ophthalmol. 2007; 143(2): Ozerturk, Y., Sari, ES., Kubaloqlu, A., Koytak, A, Pinero, D., Akyol, S. Comparison of deep anterior lamellar keratoplasty and intrastromal cornela ring segment implantation in advanced keratoconus. J Cataract Refract Surg. 2012; 38(2): Hayes, Inc. Medical Technology Directory. Laser In Situ Keratomileusis. Hayes, Inc. Lansdale, PA. October 13, El-Maghraby, A., Salah, T., Waring, GO 3 rd., Klyce, S., Ibrahim, O. Randomized bilateral comparison of excimer lase in situ keratomileusis and photorefractive keratectomy for 2.50 to 8.00 diopters of myopia. Ophthalmology. 1999; 106(3): Dulaney, DD., Barnet, RW., Perkins, SA., Kezirian, GM. Laser in situ keratomileusis for myopia and astigmatism: 6 month results. J Cataract Refract Surg. 1998; 24(6): Zadok, D, Maskaleris, G., Montes, M., Shah, S., Garcia, V., Chayet, A. Hyperopic laser in situ keratomileusis with the Nidek EC-5000 excimer laser. Ophthalmology. 2000; 107(6): Lindstrom, RL., Linebarger, EJ., Hardten, DR., Houtman, DM., Samuelson, TW. Early results of hyperopic and astigmatic laser in situ keratomileusis in eyes with secondary hyperopia. Ophthalmology. 2000; 107(10): Chao, C., Stapleton, F., Zhou, X., Chen, S., Zhou, S., Golebiowski, B. Structural and functional changes in corneal innervations after laser in situ keratomileusis and their relationship with dry eye. Graefe s Arch Clin Exp Ophthalmol Bamashmus, MA., Hubaish, K., Alawad, M., Alakhlee, H. Functional outcome and patient satisfaction after laser in situ keratomileusis for correction of myopia and myopic astigmatism. Middle East Afr J Ophthalmol. 2015; 22(1): Kato, N., Toda, I., Hori-Komai, Y., Sakai, C., Tsubota, K. Five year outcome of LASIK for myopia. Ophthalmology. 2008; 115(5): Alio, JL., Muftuoglu, O., Ortiz, D., Perez-Santonja, JJ., Artola, A., Ayala, MJ., Garcia, MJ., de Luna, GC., Tenyear follow-up of laser in situ keratomileusis for high myopia. Am J Ophthalmol. 2008; 145(1): Zhao, LQ., Wei, RL., Cheng, JW., Li, Y., Cai, JP., Ma, X. Meta-analysis: clinical outcomes of laser-assisted subepithelial keratectomy and photorefractive keratectomy in myopia. Ophthalmology. 2010; 117(10):1912.

13 25. Teus, MA., de Benito-Llopis, L., Garcia-Gonzalez, M. Comparison of visual results between laser-assisted subepithelial keratectomy and epipolis laser in situ keratomileusis to correct myopia and myopic astigmatism. Am J Ophthalmol. 2008; 146(3): Pop, M., Payette, Y., Photorefractive keratectomy versus laser in situ keratomileusis: a control-matched study. Ophthalmology. 2000; 107(2): American Academy of Ophthalmology (AAO). Preferred Practice Patterns: Refractive Errors and Refractive Surgery. September, 2007; reprinted 2009; updated July 2013.